Process Engineer

Tandem Project Management Ltd.; Waterford; On-site; EUR 45,000 - 60,000; Full time

Job summary

A leading company is looking for a Process Engineer to support pre-filled syringe operations within a sterile manufacturing environment. The successful candidate will be responsible for ensuring compliance, technical support, and continuous improvement of key manufacturing processes while liaising with vendors and managing project deliverables.

Qualifications

• 3 or more years’ relevant experience in a highly regulated GMP environment.
• Experience of Sterile Manufacturing Operations would be an advantage.
• Experience in syringe filling would be a distinct advantage.

Responsibilities

• Act as Process Engineer for pre-filled syringe operation.
• Lead problem-solving for technical issues and own change controls.
• Support day-to-day operations and deliver continuous improvement projects.

Skills

Problem Solving

Technical Support

Project Management

Education

Honours degree in Engineering

Job description

Summary:
Our client is looking for Process Engineer to join its team to support existing business as usual daily functions and on-going continuous improvement pre-filled syringe processes. The successful candidate will support the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

Responsibilities:

• Act as Process Engineer for project/ programs associated with pre-filled syringe operation.
• Filter test development.
• Fill weight cycle development.
• Cleaning verification.
• Documentation Generation/Execution e.g. recipe documents, FMEAs, Protocols, Reports etc.
• Leading problem-solving investigations for technical issues as well as owning change controls.
• Delivering activities on schedule and within budget.
• Supporting day-to-day operations of the syringe filling area through investigations, identify and deliver corrective actions including continuous improvement projects.
• Communicate and liaise with material/component vendors during project.
• Execute Process Engineering activities to schedule and to the appropriate compliance and safety standards.
• Writing of Process/Operational Control Strategy documents (detailing control over Critical Process Parameters), Failure Mode Effect Analysis (FMEA) and supporting Operator training.
• Coordinating and ownership of deliverables to meet project timelines and cost.
• Generation of hour-by-hour schedules for planning line time and execution of deliverables.
• Other responsibilities will be to provide support where required on the existing Aseptic Syringe Filling Line and supporting processes which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
• Support commercial manufacturing through delivery of key performance metrics (SQDCI).
• Role may require travel to other sites or vendor sites.
• Participate in site GMP regulatory and safety audits.
• Provide technical support to implement process improvements, new product transfers to the site and production.

Qualifications & Experience:

• Honours degree in an Engineering discipline.
• 3 or more years’ relevant experience in a highly regulated GMP environment.
• Experience of Sterile Manufacturing Operations would be an advantage.
• Experience in syringe filling would be a distinct advantage.
• Experience in new product introduction would be a distinct advantage.